Evaluation of the Scanning Accuracy of Scanners Operating With Different Scanning Technologies in Mandibular and Maxillary Edentulous Ridges

NCT07209826 | Active Not Recruiting

• 1 other identifier: Ege-DHF-ASN-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the scanning accuracy of scanners equipped with Active Triangulation, Confocal Microscopy, and Multi-Direct-Capture technologies. Department of Prosthetic Dentistry, Faculty of Dentistry, Ege University , 30 patients who applied for a complete removable denture and met the inclusion criteria will have conventional impressions taken. The resulting master model (reference scan) will be scanned using an industrial scanner with high scanning accuracy (E4 lab scanner, 3shape, Denmark) to obtain digital data. Edentulous ridges; Active Triangulation (Medit i700, Seoul, South Korea), Confocal Microscopy (Trios 5, Henry Schein Dental, Gillingham, Kent, UK), and Multi-Direct-Capture technologies (iTero Lumina, Align Technologies, San Jose, California, USA) will be scanned three times using the scanning protocols recommended by the manufacturers and digitized. All digital data obtained will be evaluated using Geomagic (Studio 2015; 3D Systems Inc., Darmstadt, Germany) 3D analysis software to match the reference data and verify its accuracy according to the accepted reference measurement.

Conditions

Accuracy; Measurement Reliability

Keywords

intra-oral scanner; digital impression; Complete Edentulism

Outcome Measures

Primary Outcomes (1)

• Accuracy of Intraoral Scanners Compared With Reference Extraoral Scanner

  The primary outcome is the trueness (accuracy) of three intraoral scanners (Trios 5, Medit i700, iTero Lumina) in capturing edentulous maxillary and mandibular arches. Accuracy will be assessed by comparing the surface deviation of intraoral scan data to the reference dataset obtained from the extraoral laboratory scanner of a conventional stone cast. Mean root-mean-square (RMS) error values (measured in micrometers, µm) will be calculated for each scanner relative to the reference to quantify the deviation.

  Two months

Study Arms (4)

Trios 5 Intra-oral scanner

EXPERIMENTAL

It is an intraoral scanner that works with confocal microscopy scanning technology. The purpose of using the intraoral scanner in our work is to take intraoral digital measurements by scanning edentulous ridges. They record the patient's intraoral images in high resolution.

Other: iTero Lumina; Other: Medit i700; Other: E4 Lab Scanner

Medit i700 Intra-oral Scanner

EXPERIMENTAL

It is an intraoral scanner that works with active triangulation scanning technology. In our study, the purpose of using the intraoral scanner is to take intraoral digital measurements by scanning edentulous ridges. They record the patient's intraoral images in high resolution.

Other: Trios 5; Other: iTero Lumina; Other: E4 Lab Scanner

iTero Lumina Intra-oral Scanner

EXPERIMENTAL

It is an intraoral scanner that works with multi-unit-capture scanning technology. In this study, using the new generation digital scanning technology of iTero Lumina, intraoral digital measurements are taken by scanning edentulous ridges. They record the patient's intraoral images in high resolution.

Other: Trios 5; Other: Medit i700; Other: E4 Lab Scanner

E4 Lab Scanner Extra-oral Scanner

ACTIVE COMPARATOR

The 3Shape E4 laboratory scanner (EOS) is a desktop laboratory scanner with an indirect scanning procedure. It features fast and accurate scanning technology. With 3Shape E4 scanners, the scanning process begins as soon as you place the model inside the scanner. It records the digital measurement data of the model. In our study, the primary model (reference scan) obtained by taking conventional measurements from the patient is scanned using a laboratory scanner, and digital data is obtained.

Other: Trios 5; Other: iTero Lumina; Other: Medit i700

Interventions

Trios 5 OTHER

Each patient's edentulous ridges are planned to be scanned three times with Trios 5.To ensure optimum accuracy, scans were performed in a standard dark environment in accordance with the manufacturer's scanning protocols.

E4 Lab Scanner Extra-oral Scanner; Medit i700 Intra-oral Scanner; iTero Lumina Intra-oral Scanner

iTero Lumina OTHER

Each patient's edentulous ridges are planned to be scanned three times with iTero Lumina.To ensure optimum accuracy, scans were performed in a standard dark environment in accordance with the manufacturer's scanning protocols.

E4 Lab Scanner Extra-oral Scanner; Medit i700 Intra-oral Scanner; Trios 5 Intra-oral scanner

Medit i700 OTHER

Each patient's edentulous ridges are planned to be scanned three times with Medit i700.To ensure optimum accuracy, scans were performed in a standard dark environment in accordance with the manufacturer's scanning protocols.

E4 Lab Scanner Extra-oral Scanner; Trios 5 Intra-oral scanner; iTero Lumina Intra-oral Scanner

E4 Lab Scanner OTHER

Conventional measurements will be taken from each patient, and the resulting master model (reference scan) will be scanned using an industrial scanner with high scanning accuracy (E4 lab scanner, 3shape, Denmark) to obtain digital data.

Medit i700 Intra-oral Scanner; Trios 5 Intra-oral scanner; iTero Lumina Intra-oral Scanner

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 to 80
• Upper and lower edentulous ridges
• Individuals who have not received radiation therapy or chemotherapy
• Individuals who have not been diagnosed with dry mouth
• Individuals without active mouth sores due to systemic diseases
• Patients who accept the study conditions will be included in the study.

You may not qualify if:

• Patients whose extraction site has not yet healed or whose last tooth extraction was less than 2 months ago
• Individuals who have undergone radiation therapy and chemotherapy
• Individuals diagnosed with dry mouth
• Individuals with active mouth sores due to systemic diseases
• Patients who do not agree to the study conditions will not be included in the study.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University,Faculty of Dentistry,Department of Prosthodontics,Izmir

Izmir, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: April 10, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-04

Locations

TU (1)